Principal Strategic Medical Writer

Summary

Join AbbVie as a Principal Strategic Medical Writer and lead the creation of clinical and regulatory documents. You will independently write documents, coordinate reviews, and ensure quality control. Collaborate with cross-functional teams, manage projects, and contribute to process improvements. Develop expertise in US and international regulations and apply therapeutic area knowledge to projects. Maintain an inspection-ready approach and work with R&D Quality Assurance. This role requires strong communication, writing, and analytical skills, along with extensive experience in the biopharmaceutical industry.

Requirements

• A minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas
• Bachelor's Degree or higher in a scientific discipline
• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
• Proficient in assimilating and analyzing complex data
• Extensive experience writing, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
• Excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders
• Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills

Responsibilities

• Independently write most clinical and regulatory documents within their remit
• Coordinate the review, approval, and quality control processes involving other functions in the production of clinical and regulatory documents
• Arrange and conduct review meetings with the team to ensure thorough examination of content
• Work closely with teams on document authoring and content strategies to ensure alignment with project goals
• Communicate deliverables needed, the writing process, and timelines to team members, ensuring clarity and understanding of expectations
• Hold team members accountable to agreed-upon project dates, contributing to the success of timely submissions
• Contribute to project management strategies and develop the ability to lead team members, driving toward submission objectives
• Recommend, lead, and participate in the implementation and execution of tactical process improvements to enhance efficiency and effectiveness
• Develop expert knowledge of US and international regulations, requirements, and guidance associated with the preparation of regulatory documentation
• Identify and propose solutions to resolve issues and questions that arise during the writing process, including resolution or escalation as appropriate
• Learn and apply therapeutic area and product knowledge to scientific projects and business improvement initiatives
• Work independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs